What is Personalized Medicine ?

by

This is a revolutionary approach in healthcare that customizes medical treatment to the individual characteristics of each patient. Fig.: – 01 Personalized Medicine In other words, Personalized medicine also known as precision medicine. It involves the customization of healthcare, with decisions and treatments being tailored to the individual patient by integrating genetic, environmental, and lifestyle … Read more

Pharmaceutical Science: What You Need to Know?

by

Pharmaceutical science covers a diverse field focused on the
discovery,
development, and evaluation of drugs intended for medical purposes. It is the combination of
elements of biology, chemistry, pharmacology, and technology to formulate
medications that enhance human health effectively. 

From initial Research and
Formulation to Clinical Trials and Regulatory Approval, pharmaceutical
scientists play a crucial role in every stage of drug
development. 

Their efforts not only tackle existing health issues but also
drive forward medical innovation, striving to expand treatment choices and
improve global quality of life.

In
continuation to introduction of Pharmaceutical science, we can say it is a
broad field with several specialized branches.

Pharmaceutical science is a TREE 🌳🌳 have some key branches 🎋, each contributing uniquely to its comprehensive field of study:

5 Common Issues Encountered During Process Validation and solutions

by

Process validation is a critical aspect of
pharmaceutical manufacturing, ensuring that products meet their intended
quality standards consistently.

However, the path to successful process
validation is often troubled with challenges. In this article, we will explore
common issues encountered during process validation and provide practical
solutions to overcome them.

1.    Incomplete or Inadequate Validation Protocols.
2.    Inconsistent Data and Poor Data Integrity
3.    Equipment and Instrumentation Failures
4.    Variability in Raw Materials
5.    Process Deviations and Non-Conformances

Issues Encountered During Process Validation and solutions
Issues Encountered During Process Validation and solutions


Incomplete or Inadequate Validation Protocol

Lack of comprehensive documentation can hinder
the validation process. Incomplete or poorly organized records make it
difficult to demonstrate compliance with regulatory requirements.

Among this, one of the most significant
challenges in process validation is developing robust validation protocols.
Common issues include a lack of clear objectives, poorly defined acceptance
criteria, and insufficient procedural details.

Have a Validation Master Plan and specific
procedure to guide you as to the who, what, when, why of validation at your
facility, and how those validations are conducted.

SOLUTION:

🔑    Develop comprehensive validation protocols with
clearly defined objectives, detailed procedures, and specific acceptance
criteria.


🔑    Ensure protocols are reviewed and approved by
qualified personnel.

🔑    Use standardized templates for protocols.

Read more

What does SISPQ stands for? In Pharmaceutical Industry

by

When we discuss the pharmaceutical manufacturing, SISPQ is very important topic of discussion. It adheres the basic principle and objective of Pharmaceutical Manufacturing i.e.  “The pharmaceutical industry aims to guarantee patient safety by producing a safe product which has been tested according to the highest standard of current scientific knowledge and which is approved by … Read more

Understanding Impurities in Drug Substance and Control Strategies

by

In General terms Impurity is referred as something, which is not pure. Some substance / component that may affect the SISPQ (Safety, Identity, Strength, Purity and Quality) of a drug substance/drug products (Ref.USP). Therefore, studies of impurities are one of the most important works in the development of APIs and drug products. We will understand the below details under … Read more

What is Regulatory Dossier in Pharmaceutical Industry?

by

Regulatory Affairs is a profession, known as a bridge / a channel of communication, between the Regulatory Agency and the organization seeking approval for new pharmaceutical products.  It plays an important role in Product Life Cycle management stages from “Drug development” to “Commercialization”. For the getting approval of new Products in various countries all over … Read more

Green Chemistry in Drug Substance Synthesis

by

The concept of Green Chemistry accepted by the scientific community, the technical Green Chemistry evolution is yet to achieve with the appropriate attention and effort which only possible through education and awareness. Green Chemistry has the potential to transform the pharmaceutical industry and drug manufacturing in the future. It provides benefit both environmentally and economically. It will … Read more

Artificial intelligence and Automation in pharmaceutical 💊 industry

by

Artificial Intelligence and Automation in Healthcare, these are key step for Revolutionizing Pharma Artificial-intelligence-in-pharmaceutical-Industry How to define Artificial intelligence and Automation: Artificial intelligence is a broader concept that covers the simulation of human intelligence by machines, while Automation refers to the use of technology to perform tasks with minimal human intervention. AI systems are typically more flexible and capable of learning … Read more

What is the difference between clinical trial & clinical research?

by

These two terms are differ in scope and methodology, clinical trials and clinical research are essential components of medical innovation. In this article we will try to define clinical trial & clinical research in comparatively in brief.   Clinical research is a wide range of scientific investigation that aims to comprehend illnesses, medical procedures, and therapeutic methods. … Read more

What is Marketing Authorization in Pharmaceutical Industry?

by

In the world of pharmaceutical industry, Marketing Authorization term is being used for formal approval process, by which various regulatory agency grant permission for the commercial distribution and sale of a Pharmaceutical Product. Marketing Authorization is an official document issued by the regulatory agency for the purpose of marketing of a product after evaluation for … Read more